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What is the optimal treatment of a patent ductus arteriosus in preterm infants?


- candidate number22986
- NTR NumberNTR5479
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-okt-2015
- Secondary IDsZonMw project number 843002633
- Public TitleWhat is the optimal treatment of a patent ductus arteriosus in preterm infants?
- Scientific TitleMulti-centre, randomized non-inferiority trial of early treatment versus expectative management of patent ductus arteriosus in preterm infants
- ACRONYMBeNeDuctus
- hypothesisAn expectative management ('watchful waiting') is not inferior regarding the composite of mortality and/or necrotising enterocolitis and/or bronchopulmonary dysplasia in comparison with an early treatment regime in preterm infants with a patent ductus arteriosus.
- Healt Condition(s) or Problem(s) studiedPremature infants, Patent ductus arteriosus, Neonates
- Inclusion criteria- Gestational age < 28 completed weeks
- PDA diameter > 1.5 mm
- Signed informed consent obtained from parent(s) or representative(s)
- Exclusion criteria- Contraindication to administration of COX-inhibitors
- PPHN (ductal right-to-left shunting ≥ 33% of cardiac cycle)
- Congenital heart defects, other than PDA and or PFO
- Life-threatening congenital defects
- Chromosomal abnormalities and/or congenital anomalies associated with an abnormal neurodevelopmental outcome
- Use of COX-inhibitors or paracetamol prior to randomization
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jul-2016
- planned closingdate14-dec-2019
- Target number of participants564
- InterventionsPatients randomized to the expectative management arm will not receive any cyclooxygenase-inhibition and PDA management in this group can be characterized as 'watchful waiting'.
When the patient is allocated to the medical treatment arm cyclooxygenase-inhibition is prescribed (Indomethacin or Ibuprofen). When the ductus arteriosus has remained patent after the first course of cyclooxygenase-inhibition, a second course is started.
- Primary outcomeThe composite of:
- mortality at a postmenstrual age of <= 36 completed weeks, and/or
- necrotising enterocolitis (Bell stage >= IIa) at a postmenstrual age of <= 36 completed weeks, and/or
- bronchopulmonary dysplasia, defined as the need for supplemental oxygen at a postmenstrual age of 36 completed weeks
- Secondary outcomeShort term sequelae of cardiovascular failure, adverse effects during the stay in the hospital and long-term neurodevelopmental consequences assessed at a corrected age of 2 years.
- TimepointsPrimary outcome at a postmenstrual age of <= 36 completed weeks
Neurodevelopment at a corrected age of 2 years
- Trial web site http://neonatologynetwork.eu/studies/beneductus
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD PhD Willem P. de Boode
- CONTACT for SCIENTIFIC QUERIESMD PhD Willem P. de Boode
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summaryOBJECTIVE Much controversy exists about the optimal management of a patent ductus arteriosus (PDA) in preterm infants, especially in those born at a gestational age (GA) <28 weeks. Studies have shown that the actual approach with medical and/or surgical treatment of a PDA does not reduce mortality or major neonatal morbidity. This implies that this high risk population might be over-treated with an increased iatrogenic risk of adverse effects related to the used drugs and/or surgery. An expectative approach is gaining interest, although convincing evidence is still lacking.

HYPOTHESIS An expectative management (‘watchful waiting’) is not inferior regarding the composite of mortality and/or necrotizing enterocolitis (NEC) and/or bronchopulmonary dysplasia (BPD) in comparison with an early treatment regime in preterm infants with a PDA.

STUDY DESIGN Multicenter, randomized, non-inferiority study.

STUDY POPULATION Preterm infants (<28 weeks) with an echocardiographically confirmed PDA with a transductal diameter >1.5 mm.

INTERVENTION Expectative PDA management is characterized as ‘watchful waiting’. No intervention is initiated with the intention to close a PDA.

USUAL CARE A PDA is treated with cyclooxygenase-inhibitors (COXi), which is the actual standard care in preterm infants with GA<28 weeks, and if necessary surgical ligation.

OUTCOME MEASURES The primary outcome is the composite of mortality and/or NEC and/or BPD. Secondary outcome parameters are short term sequelae of cardiovascular failure, adverse effects during the stay in the hospital and long-term neurodevelopmental consequences assessed at an corrected age of 2 years.

SAMPLE SIZE CALCULATION With an estimated a priori risk for the primary outcome of 35%, type I error 5%, power 80% and non-inferiority, defined as a difference between the arms <10%, a sample size of 282 patients is needed in each arm.

COST-EFFECTIVENESS ANALYSIS/ BUDGET IMPACT ANALYSIS It is anticipated that an expectative PDA management will be cost-effective from a societal perspective with an annual budgetary saving of about €800.000, based on reduction in medical treatments and diagnostics.
- Main changes (audit trail)
- RECORD19-okt-2015 - 5-jan-2016


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